MEIJER  DRY MOUTH- sodium fluoride paste, dentifrice 
Meijer Distribution Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Meijer Dry Mouth

Drug Facts

Active ingredient

Sodium Fluoride (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

Warnings

Keep out of reach of children 12 years of age and under. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older: Apply onto a soft bristle toothbrush.

Children under 12 years of age: consult a dentist or physician. Once recommended, to minimize swallowing for children under 6,use a pea sized amount and supervise brushing until good habits are established.

Other information

Store in a cool dry place. Keep tube capped when not in use.

Inactive ingredients

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Titanium Dioxide, Sodium Hydroxide.

DIST. BY

MEIJER DISTRIBUTION INC.

GRAND RAPIDS, MI 49544

www.meijer.com

meijer™

Dry Mouth Toothpaste

Anticavity Toothpaste with Fluoride

Fresh Mint

Helps soothe dry mouth symptoms

NET WT. 4.3 OZ (122 g)

MeijerDrymouth 2821280R1

MEIJER   DRY MOUTH
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-531
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.243 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLYCERIN (UNII: PDC6A3C0OX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-531-291 in 1 CARTON02/25/2019
1122 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/25/2019
Labeler - Meijer Distribution Inc (006959555)
Registrant - Lornamead Inc. (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead Inc.080046418manufacture(41250-531)

Revised: 1/2023
Document Id: f1fed72d-f6cd-5e5d-e053-2a95a90a053a
Set id: 82bdcb21-7bf3-53bb-e053-2a91aa0abd81
Version: 10
Effective Time: 20230111
 
Meijer Distribution Inc